QKO

Reagent, Coronavirus Serological

Product code
QKO
Device name
Reagent, Coronavirus Serological
Device class
Class N
Medical specialty
Unknown
Marketing pathway
EUA - Emergency Use Authorization

FDA classification definition

The qualitative detection of IgM and/or IgG antibodies to coronavirus from human specimens.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QKO
Classification and pathway per current FDA publications. Data from openFDA (CC0).